TEVA MOCLOBEMIDE 300MG FILM-COATED TABLETS

Transcript

MOCLOBEMIDE 150 MG AND 300 MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet See section 4..
WHAT IS IN THIS LEAFLET:
1. What Moclobemide is and what it is used for
2. What you need to know before you take Moclobemide
3. How to take Moclobemide
4. Possible side effects
5. How to store Moclobemide
6. Contents of the pack and futher information

1.

WHAT MOCLOBEMIDE IS AND WHAT IT IS USED FOR

Moclobemide belongs to a group of drugs known as antidepressants.
Moclobemide is used to treat major depressive episodes.
monoamine oxidase inhibitor antidepressant.

This medication is called a

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOCLOBEMIDE
Do not take Moclobemide if you:
• are allergic (hypersensitive) to moclobemide or any of the other ingredients of this
medicine (listed in section 6).
• suffer from confusion
• have a phaeochromocytoma (a tumour of the adrenal gland that produces hormones that
can raise blood pressure)
• are under the age of 18
are taking any of the medicines listed in the section below called “Other medicines and
Moclobemide” under heading “DO NOT take Moclobemide in combination with, or if you
have recently taken”.
Warnings and precautions
Talk to your doctor before taking Moclobemide if you have any of the following:
Thoughts of suicide and worsening of your depression
If you are depressed you can sometimes have thoughts of harming or killing yourself. These
may be increased when first starting antidepressants, since these medicines all take time to
work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
• if you have previously had thoughts about killing or harming yourself
• if you are a young adult. Information from clinical trials has shown an increased risk
of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who
were treated with an antidepressant.
* Only marketed pack sizes will be included in the printed version of the PIL
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If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed
and ask them to read this leaflet. You might ask them to tell you if they think your
depression is getting worse, or if they are worried about changes in your behaviour.
If you stop taking other antidepressants you should usually wait for some time
before starting to take Moclobemide. This is to avoid serotonin syndrome. Your
doctor will tell you how long you must wait.

Excitation and nervousness (agitation)
If the main symptoms of your depression are excitation or nervousness
(agitation) you should either:
• not take Moclobemide at all or
• only take Moclobemide together with a sedative and not for longer than 2 to 3
weeks.
Bipolar disorder
If you have bipolar disorder, you should use Moclobemide with caution. If you
have bipolar disorder, there will be:
• times when you are feeling depressed (sad)
• times when you suffer from bouts of mania/hypomania
Symptoms of mania/hypomania include:
being overexcited
being overactive
a feeling of elation
an excessive feeling of well-being and self-importance
agitation
increased speed of thought and speech
If you suffer from a bout of mania you should stop taking Moclobemide
If you suffer with schizophrenia and similar mental disorders
You should not take Moclobemide unless you also take medication to treat
your schizophrenia.
High blood pressure
Your doctor will monitor your blood pressure closely during treatment. You should take
particular care if you have an overactive thyroid gland or pheochromocytoma. An
overactive thyroid gland can product too much of a hormone called thyroxine
(thyrotoxicosis). A pheochromocytoma is a tumour of the adrenal gland that produces
hormones that can raise blood pressure).
Talk to your doctor before you start to take this medicine if you:
• have high blood pressure
• suffer from thyrotoxicosis (an overactive thyroid gland, often called Graves’ Disease)
• suffer from galactose intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption
• have liver problems
• are pregnant or breast-feeding.

If you need an operation requiring an anaesthetic tell the hospital or dentist you are taking
Moclobemide.

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Other medicines and Moclobemide
DO NOT take Moclobemide in combination with, or if you have recently taken:
• selegiline (used to treat Parkinson’s disease)
• linezolid (used to treat serious infections of skin and soft tissues and respiratory tract
infections)
• any other antidepressants e.g. clomipramine, fluoxetine, fluvoxamine, venlafaxine,
citalopram, escitalopram, paroxetine, sertraline, bupropion, phenelzin,
tranylcypromine. This combination of treatment can cause the development of
serotonin syndrome which can be life-threatening.

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Symptoms of serotonin syndrome include
• rise in body temperature
• confusion
• stiffness (rigidity)
• irritability (when you are easily angered or annoyed)
• increased heartbeat (tachycardia)
• rise in blood pressure
• shaking (tremors)
If you stop treatment with selective serotonin reuptake inhibitors SSRIs, you
must wait for some time before starting to take Moclobemide (your doctor will tell
you how long).
In isolated cases severe reactions affecting the nervous system have occurred
when dextromethorphan is taken with Moclobemide.
pethidine (used to relieve pain during labour or after surgery)
tramadol (used to relieve pain)
triptans (used to treat migraine) e.g. sumatriptan, rizatriptan, zolmitriptan,
almotriptan, naratriptan, frovatriptan and eletriptan.). This combination of treatment
can cause high blood pressure and chest pain (angina).

Tell your doctor if you are taking, have recently taken or might take any other
medicines:
• morphine, fentanyl, dextropropoxyphene (used to relieve pain) as your doctor may
need to reduce the dose
• codeine (used to treat a cough) as your doctor may need to reduce the dose
• cimetidine, omeprazole(used to treat stomach ulcers or indigestion) as your
doctor may need to reduce the dose of Moclobemide
• trimipramine and maprotiline (antidepressants)
• buspirone (used to treat anxiety)
• St. John’s Wort (Hypericum perforatum), a herbal remedy used for depression
• sympathomimetics e.g. adrenaline, noradrenaline, ephedrine, pseudoephedrine
or phenylpropanolamine, or are currently taking cough or cold remedies which
may contain some of these ingredients.
• sibutramine (used to help weight loss)

Moclobemide with food, drink and alcohol
• DO NOT drink alcohol whilst you are taking Moclobemide.
• DO NOT eat large amounts of foods rich in tyramine. Tyramine is a chemical
found naturally in food, especially fermented foods such as mature cheese, red
wine, yeast extracts and fermented soya bean products.

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Pregnancy, breast-feeding and fertility
• If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have babay, ask your doctor for advice before taking this medicine.
Driving and using machines
• Moclobemide may cause dizziness or vision problems. If you are affected do
not drive or use machinery.
Moclobemide contains lactose
Patients who are intolerant to lactose should note that Moclobemide Tablets contain a small
amount of lactose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE MOCLOBEMIDE
Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Your doctor will tell you how long you should take Moclobemide. You should take
Moclobemide for at least 4 to 6 weeks. This is so your doctor can judge how well it
is working. During treatment your doctor may want to monitor you closely,
especially at the beginning of treatment and also if the dose is changed.
Ideally you should take Moclobemide until you have had no symptoms of
depression for 4 to 6 months. Your doctor will then gradually reduce and stop your
treatment.
The tablets should be swallowed preferably with a glass of water. The
recommended dose is:
• Adults (including the elderly):
Initially 300 mg a day taken in divided doses after meals. Your doctor may adjust
your dose depending on your response to the drug. The minimum daily dose is 150
mg and the maximum daily dose is 600 mg.
• Patients with liver problems:
Your doctor will prescribe a lower dose.
• Children:
Moclobemide is not recommended for use in children.
If you take more Moclobemide than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a
child has swallowed any of the tablets, contact your nearest hospital casualty
department or your doctor immediately. You may suffer serious effects, especially if
you have taken other medicines, for example, other medicines that affect the
nervous system.
An overdose is likely to cause increasing agitation, aggressiveness, changes in
behaviour or stomach upset. Overdose in some cases has been life-threatening.
Please take this leaflet, any remaining tablets, and the container with you to the
hospital or doctor so that they know which tablets were consumed.
If you forget to take Moclobemide
If you forget to take a tablet, take one as soon as you remember, unless it is nearly
time to take the next one. DO NOT take a double dose to make up for a forgotten
dose. Take the remaining doses at the correct time.
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If you stop taking Moclobemide
You should continue to take these tablets for as long as your doctor tells you to. DO
NOT stop taking Moclobemide without talking to your doctor first, even if you feel
better, this can cause withdrawal symptoms.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
If the following happens, stop taking the tablets and tell your doctor
immediately or go to the casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck leading to severe
difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention
or hospitalisation.
Contact your doctor immediately if you experience:
• high body temperature, confusion, rigidity, irritability, fast heart rate, a rise in
blood pressure and shaking. This may be a condition called serotonin
syndrome and has been reported rarely when Moclobemide is given in
combination with other antidepressants such as clomipramide and selective
serotonin re-uptake inhibitors (SSRIs). You must not take Moclobemide
together with SSRIs or clomipramine (see section 2, subheading “Do NOT
take Moclobemide if you:”.
If you stop taking SSRIs you must wait for some time before starting to take
Moclobemide. This is to avoid Serotonin syndrome. Your doctor will tell you how
long you must wait.
The following effects may occur during the first few weeks of therapy but will usually
disappear with improvement of your depression:

Uncommon: may affect up to 1 in 100 people
• Cases of suicidal thoughts and suicidal behaviours have been reported during
moclobemide therapy or early after treatment has been stopped.
• Confusion may be experienced, but this disappears when the treatment is stopped.
• Taste disorder (Dysgeusia)
• Problems with vision
• Flushing
• Oedema (fluid retention e.g. hands and feet)
• Skin reactions such a nettle rash, itching
• Asthenia
Rare: may affect up to 1 in 1000 people
• Decreased appetite
• Low level of natrium in your blood
• Suicidal behaviour, delusion
• Abnormal liver function tests (detected by a blood test) have also been
reported.
Very rare: may affect upto 1 in 10,000 people
• Spontaneous production of breast milk which is not due to pregnancy or
breast-feeding

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE MOCLOBEMIDE
Keep out of the sight and reach of children.
No special precautions for storage.
Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry
date refers to the last day of that month.
Do not through away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

What Moclobemide Tablets look like and contents of the pack:
• The Moclobemide Film-Coated Tablets 150 mg are beige, oval-shaped, bevel-edged, filmcoated tablets. They have a deep breakline on one side and are engraved with ‘MCL 150’ on
the other.
• The Moclobemide Film-Coated Tablets 300 mg are white to off-white, oval-shaped, beveledged, film-coated tablets. They have a deep breakline on one side and are engraved with
‘MCL 300’ on the other.
• The 150 mg tablets are available in pack sizes of 20, 28, 30, 50, 84 and 100 film-coated
tablets. The 300 mg tablets are available in pack sizes of 15, 16, 20, 28, 30, 50, 60 and 100
film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder: Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The
Netherlands
Company responsible for manufacture: Pharmachemie B.V., Haarlem, The Netherlands
This leaflet was last revised: June 2015
PL 14776/0060-61

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.